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NCT01251601 Clinical Trial

The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

HIV Clinical Trial

Official title:
The Effect of Pregnancy on the Pharmacokinetics of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01251601
Other study ID # 10-1691
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2010
Est. completion date September 2011

Study information
Verified date January 2012
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - HIV Infected - Pregnant - At least 18 years of age - Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum Exclusion Criteria: - Less than 18 years of age - Hemoglobin <9 g/dL or Hematocrit <27.3 at screening

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pharmacokinetics
Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Merck Sharp & Dohme LLC
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